Vascular Remodeling After Living Kidney Donation Study (EUGENIA)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Living Kidney Donation

Treatments: Diagnostic Test: Vascular remodeling characterization

Study type: Interventional

Funder types: Other

Identifiers

NCT05073913

IDRCB 2020-A00723-36 (Other Identifier)

APHP191038

Details and patient eligibility

About

Vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. The implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of vascular remodeling in donors have so far been poorly described. The object of the present study is to study the evolution of vascular remodeling of small, medium and large vessels (until then not evaluable by standard techniques) before and one year after living kidney donation, by dedicated-, non invasive-examinations, which results are associated with cardiovascular risk in the general population. This approach will make it possible to precisely assess the impact of unilateral nephrectomy on vascular remodeling after living donation and to estimate the change in cardiovascular risk attributable to the donation. These results will also help refine the assessment of candidates for kidney donation and potentially open up new strategies to improve selection process of candidates to living kidney donation. Of note, we also plan to evaluate one year after the first exploration potentiel living kidney donors who did not give their kidney due to medical or non medical reasons, as a control group.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• candidate to living kidney donation
• affiliated to national health insurance
• capable of understanding the consequences of participating to the study
• written informed consent

Exclusion criteria

• pregnancy
• breastfeeding
• allergy to iodinated contrast agents
• allergy to echographic gel, allergy to cutaneous dressings
• cutaneous lesions preventing the ultrasonography probe to be applied on the skin
• participation to a drug trial

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Living kidney donors

Active Comparator group

Description:

complete vascular exploration before and one year after nephrectomy

Treatment:

Diagnostic Test: Vascular remodeling characterization

potential living kidney donors

Sham Comparator group

Description:

complete vascular exploration before and one year after the first exploration (for patients with medical contraindication to donation or who have declined donation after the first exploration)

Treatment:

Diagnostic Test: Vascular remodeling characterization